Sterile surgical tray

ABSTRACT

A surgical apparatus for use by a surgeon can include a tray and a plurality of surgical instruments. The tray can have a plurality of structures located on an upper side of the tray for receiving the plurality of surgical instruments. The tray can receive a separate control unit. The tray can also have a fluid reservoir receiver for receiving a bottle or container of fluid, such as balanced salt solution. The fluid reservoir receiver can include one or more features, including, a spike, an air vent, and a light. A separate container can be used to place the bottle or container of fluid into the fluid reservoir receiver on the tray. This separate container can include a collapsible section.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/312,948, titled STERILE SURGICAL TRAY, filed Dec. 6, 2011, which is acontinuation-in-part application of U.S. application Ser. No. 12/684,850(DOHENY2.009CPCP1), filed Jan. 8, 2010, which is a continuation-in-partapplication of U.S. application Ser. No. 12/256,420 (DOHENY2.009CP1),filed Oct. 22, 2008, which is a continuation-in-part application of U.S.application Ser. No. 12/107,038 (DOHENY2.009A), filed Apr. 21, 2008,which claims the benefit of U.S. Provisional Application No. 60/925,546filed. Apr. 20, 2007. U.S. application Ser. No. 12/256,420 is also acontinuation-in-part application of U.S. application Ser. No. 12/106,962(DOHENY2.011A), filed Apr. 21, 2008, which claims the benefit of U.S.Provisional Application No. 60/925,548 filed Apr. 20, 2007. U.S.application Ser. No. 13/312,948 also claims the benefit of U.S.Provisional Application No. 61/481,637 (DOHENY2.059PR) filed May 2,2011, titled STERILE BOTTLE CONTAINER AND METHOD. Each of the foregoingapplications is hereby incorporated by reference herein in its entiretyand should be considered a part of this application.

BACKGROUND

1. Field

The present invention relates generally to surgical systems and moreparticularly to sterile surgical trays that can be used with a pluralityof surgical instruments in surgical procedures.

2. Description of the Related Art

It is well known to use, in surgery, a sterile pack shipped from amanufacturer to a surgery center, an example of which is ophthalmicsurgery (vitreoretinal or cataract surgery, in particular). These packstypically contain several items that are used in surgery and may includeone-time use surgical instruments, fluid cassettes, tubing sets, drapes,needles, and other devices. The particular content of a pack depends onthe type of surgery and perhaps the individual preference of the surgeonor surgery center.

When preparing for surgery, typically a sterile drape is placed overwhat is commonly referred to as a Mayo tray. The contents of the sterilepack and perhaps additional sterile instruments and materials arespread-out over the tray so that the materials and instruments necessaryfor the surgery are readily available to a nurse or surgeon.

It is also known to provide a sterile pack where many of the instrumentsand tubing sets are organized and placed in mating recesses of the packso that the pack can act as a tray for at least some of the instrumentsin surgery.

A sterile field is generally established for many medical procedures.Such a sterile field can be used to maintain the instruments,medications, and other devices in a sterile condition. For example, insurgical procedures, the sterile field is typically defined by the areaadjacent the surgical site that is covered by a sterile drape and thearea where the previously sterilized surgical instruments and materialsare placed for access by the surgeon during surgery.

In general, surgical instruments and medications that are to enter thebody (such as the bloodstream, or penetrating the skin) must besterilized to a high sterility assurance level. Further, the preparationof injectable medications and intravenous solutions requires not only ahigh sterility assurance level, but also well-designed containers toprevent entry of adventitious agents after initial productsterilization. In addition, such instruments and medications must bemaintained in a manner to remain sterile prior to use.

SUMMARY

There exists a continuing need for improvements in surgical packs andsurgical trays and systems. There also exists a continuing need forimprovements in systems and methods to maintain sterility of the sterilefield while simplifying the number of people and systems needed for aprocedure. According to some embodiments a surgical tray can function asboth a pack to transport surgical materials and devices to a surgerysite and as a sterile tray for receiving a plurality of surgicalinstruments. The sterile surgical tray and system can also providesterile tools and instruments associated with a surgical procedure andcan reduce the need for sterile assistants to the surgeon or additionalhardware.

A surgical apparatus for use by a surgeon during a surgical procedurecan comprise a sealed sterilized surgical pack and a control unit. Thesealed sterilized surgical pack can include a plurality of surgicalinstruments and a surgical tray. The surgical tray can have many shapessuch as being substantially shaped to fit around the body part to beoperated on. The surgical tray can have a top surface configured to bepart of a sterile field of a surgical procedure and a side or bottomsurface configured to be outside of the sterile field. The side orbottom surface can include a control unit receiver. The control unit canbe configured to be received into the control unit receiver of the trayafter the surgical pack has been opened. The control unit can beconfigured to power and control operation of at least one of theplurality of surgical instruments.

In some embodiments, a surgical apparatus can comprise a sealedsterilized surgical pack and a control unit similar to that above with aplurality of surgical instruments and a surgical tray. The surgical traymay also include one or more of the following features: a plurality ofreceiving structures, at least one electrical connector, at least onefluid connector, and at least one pump connected. The plurality ofreceiving structures can be located on the top surface, each of theplurality of surgical instruments removably positioned in acorresponding one of the receiving structures. At least one of theplurality of surgical instruments can be connected to the at least oneelectrical connector. At least one of the plurality of surgicalinstruments can be connected to the at least one fluid connector. The atleast one pump can be connected to the at least one fluid connector. Thecontrol unit can be configured to power and control operation of atleast one of the plurality of surgical instruments and the pump.

In some embodiments, the control unit receiver is positioned below thesterile field. The control unit may or may not be sterile. The tray canbe disposable while the control unit is reusable. The plurality ofsurgical instruments can comprise a biological tissue cutter, and atissue illuminator. The tray can be configured to sit on a surgicalstand to the side of or on top of the patient. The procedure may be anophthalmic surgical procedure.

A surgical apparatus according to some embodiments can comprise aplurality of surgical instruments and a surgical tray. The surgical traycan be shaped to substantially fit around the head of a patient and caninclude a plurality of receiving structures located on an upper side ofthe tray and a recess for receiving a container of fluid, each of theplurality of surgical instruments removably positioned in acorresponding one of the structures. The recess can comprise a spike forinsertion into the container of fluid, and a light positioned within therecess for shining light through the container of fluid to indicate afluid level to the surgeon. The plurality of surgical instruments andthe surgical tray can be prepackaged and sterilized together.

According to certain embodiments, a surgical apparatus for use by asurgeon during an ophthalmic surgical procedure can comprise a pluralityof surgical instruments and a surgical tray. The surgical tray can besubstantially shaped to fit around the head of a patient. The surgicaltray can include a plurality of structures located on an upper side ofthe tray, at least one pump, and a recess for receiving a container ofbalanced salt solution (BSS). Each of the plurality of surgicalinstruments can be removably positioned in a corresponding one of thestructures. The recess can have a vented spike and a light. The ventedspike can have a first channel, a second channel, and a hydrophobicfilter. The first channel can be connected to the at least one pump viatubing and the second channel can be connected to the hydrophobic filterto allow air into the channel. The light can be positioned adjacent orwithin the recess, such as at a bottom or side of the recess, forshining light through the container of BSS to highlight the meniscus ofthe fluid and thereby indicate the fluid level to the surgeon.

In some embodiments, the tray is configured to sit on a surgical standto the side of or on top of the patient. The tray may include or house aprocessing unit to control operation of at least one of the plurality ofsurgical instruments and the pump. The plurality of surgical instrumentscan comprise a biological tissue cutter, and a tissue illuminator. Thelight source of the tissue illuminator can be any type of lightincluding a light emitting diode (LED). The light source can be anycolor, but in particular may be one of blue, amber, purple, and green orthe like.

A surgical apparatus according to some embodiments for use by a surgeonduring a surgical procedure can comprise a plurality of surgicalinstruments and a surgical tray. The surgical tray can comprise asubstantially U-shaped cutout at the center of the tray to allow thetray to fit around the body part to be operated on of a patient. Thesurgical tray can have a U-shaped recess on a bottom side of the traypositioned along the U-shaped cutout. The U-shaped recess can beconfigured to receive a portion of a support on a surgical table orchair such as a tray support and that the tray can be attached to thetray support. Two holes in a front surface of the tray can provideaccess to the U-shaped recess. Each hole can be configured to receive anend of the portion of the tray support. The tray can also include aplurality of structures located on an upper side of the tray, where eachof the plurality of surgical instruments is removably positioned in acorresponding one of the structures.

In some embodiments, a method of preparing for an ophthalmic surgicalprocedure can comprise one or more of the following steps. Removing alid from a lip of a container surrounding a sterile bottle. Aligning thecontainer with a recess in a sterile surgical tray, the recessconfigured to receive the sterile bottle. Placing the lip of thecontainer around the recess so that the bottle can be advanced into therecess. Compressing the container such that the lip is forced intocontact with the sterile surgical tray causing a side wall section ofthe container to collapse decreasing an overall length of the container.Inserting the bottle into the recess in the sterile surgical tray.Removing the container from covering the bottle, leaving the bottlewithin the recess.

Additional embodiments of a method may also include one or more of thefollowing additional steps. Compressing the container comprisingcollapsing an accordion-style section of the side wall of the container.Compressing the container comprises pressing downward on a bottomsurface of the container while the lip is in contact with the sterilesurgical tray. Puncturing a membrane of the bottle with a spikepositioned within the recess. Advancing the bottle onto the spike in therecess. Discarding the container.

A method of preparing for an ophthalmic surgical procedure according tosome embodiments can comprise one or more of the following steps.Removing a lid from a container holding a sterile bottle of balancedsalt solution. Inserting the bottle of balanced salt solution into arecess in a sterile surgical tray. Collapsing an accordion-style sectionof a cylindrical side wall of the container by pressing on a bottomsurface of the container while a top lip surface engages a rim on therecess in the tray. Removing the container from covering the bottle ofbalanced salt solution; leaving the bottle on the tray. Discarding thecontainer.

The method may also include one or more of: puncturing a membrane of thebottle of balanced salt solution with a spike in the recess andadvancing the bottle of balanced salt solution onto the spike in therecess.

In some embodiments, an apparatus for use in preparation for anophthalmic surgical procedure can comprise a container having aninternal chamber, a lid on the container, and a bottle of balanced saltsolution positioned within the internal chamber. The container can havea generally cylindrical side wall including a collapsible/expandablesection that can change the length of the container. The container canbe configured to collapse as the bottle of balanced salt solution isinserted into a receptacle of a sterile tray.

In some embodiments, the collapsible/expandable section comprises anaccordion shaped section. The lid can be a TYVEK lid or other similarmaterial.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are depicted in the accompanying drawings forillustrative purposes, and should in no way be interpreted as limitingthe scope of the inventions, in which like reference characters denotecorresponding features consistently throughout similar embodiments.

FIG. 1 illustrates a patient in position for a surgical procedure.

FIG. 2 shows a tray support.

FIG. 2A shows a surgical chair or bed with a tray support.

FIG. 2B shows a surgical chair or bed with a tray support and a tray.

FIG. 3 is a perspective view of a tray.

FIG. 4 shows a top view of the tray of FIG. 3.

FIG. 5 shows a front view of the tray of FIG. 3.

FIG. 6 shows a back view of the tray of FIG. 3.

FIG. 7 is the bottom of the tray of FIG. 3.

FIG. 7A shows a bottom view of a tray connected to a tray support.

FIG. 8 is a block diagram of a fluid-air exchange system.

FIGS. 9 and 10 illustrate the sides of the tray of FIG. 3 with abalanced-salt solution (BSS) container connected to the tray.

FIG. 11 shows a tray with a removable control unit.

FIGS. 12-16 are top, bottom, and side views of the control unit.

FIG. 17 is a block diagram of the components of a control unit.

FIG. 18 is a section of the tray showing the fluid reservoir receiver.

FIG. 19 is a cross-section taken along line 19-19 of FIG. 18.

FIG. 20 shows a container.

FIG. 21 shows a container with lid.

FIG. 22 shows a bottle within a container.

FIG. 23A shows a bottle within a container.

FIG. 23B shows the bottle within a container with the container in acompressed state.

FIGS. 24-27 illustrate part of a method of using a sterile bottlecontainer.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The following description will be disclosed for illustrative purposesrelative to ophthalmic surgery but those skilled in the art willappreciate that the embodiments as described herein and as claimed mayequally apply to other types of surgery and medical procedures.

A sterile surgical tray and system can beneficially provide a user suchas a doctor, surgeon, or nurse with the instruments, tools, and/ormaterials that are needed for a medical procedure. The surgical tray andsystem can provide the needed elements in a sterile manner and in aconfiguration that is ready to use after opening of the tray. The trayand system can be designed for a particular type of medical procedureand can allow the doctor, surgeon, nurse to perform the procedurewithout having to obtain other materials, or only requiring a minimalamount of other materials and/or assistance to allow the surgicalprocedure to be performed outside of an operating room, for example, ina doctor's office or a military operating room war setting. For example,the tray and system can provide all necessary surgical tools for anoperation, as well, as power and control systems for those tools.Additionally, the tray and system can provide the tools in a ready touse configuration, such as already plugged in to power connectors, fluidconnectors, aspiration connectors, etc. As another example, the tray andsystem can include a disposable tray with all of the necessary surgicaltools for an operation, and a reusable control box/unit that can beplugged into or otherwise connected to the disposable tray.

In addition to providing necessary materials on a sterile tray that canbe used during the procedure, the tray and system can provide additionalbenefits. For example, the tray can provide the materials organized in amanner that has been optimized for the procedure. As another example,the tray can allow the user to perform the procedure without requiringan assistant to help organize, obtain, and/or provide the materials tothe user. This can simplify the procedure as well as greatly reducingthe cost of the procedure. The tray and system can also allow anon-sterile assist to prepare the surgical tray and system withoutcompromising the sterile field, including connecting the control systemand connecting a container of balanced-salt solution (BSS) to the tray.

By way of example, FIG. 1 shows a patient 2 lying down on his or herback with a surgical tray 10 surrounding the head of the patient 2. Sucha patient can be prepared for a surgical procedure, including anophthalmic procedure on one or both eyes of the patient. In this type ofprocedure, the tray 10 can be part of the sterile field and can containor hold instruments and/or medications that have previously beensterilized.

In general terms, a surgical tray can provide rapid access to packagedcomponents without requiring the transfer of the components to aseparate tray or table. In this regard, the surgical tray, upon opening,serves as a sterile tray for a surgical procedure. The surgical tray cancontain instrumentations ready for use already setup on the tray. Theinstrumentations can be positioned at suitably convenient locations fromwhich the surgeon can remove, use, and put back the instrumentation whennot in use.

The tray can be a sterile surgical tray that has been manufactured andassembled as a prepackaged sterile pack that functions as a tray duringsurgery. The term pack is meant to collectively identify the surgicalinstruments and other items contained in a sterile package that isshipped from the manufacturer to a customer, such as a hospital,ambulatory surgery center, doctor's office, military setting, etc. andis for use by a surgeon, doctor, nurse, etc. to perform a medicalprocedure, such as surgery. The term tray refers to a structure thatdefines at least a portion of a surgical field and can hold fluidhandling devices, surgical instruments, and other miscellaneous items tobe used during surgery.

In a preferred embodiment, the pack can be synonymous with the tray. Thesurgical tray may be manufactured and assembled with the necessaryequipment for surgery and then enclosed in a bag or other container andsterilized. Then when the bag is opened, the tray is removed from thebag, a lid or cover is potentially removed, revealing several if not allthe instruments and other items needed for the medical procedure, suchas surgery.

The tray 10 may take the place of a traditional Mayo tray and may beplaced between the surgeon and the surgical site. During an operation,after the pack is opened by removing the covering or removing the trayfrom an enclosure, the tray 10 may be placed at the left or right sideof the surgeon, on or over the patient's chest, or on another surgicalapparatus such as a surgical stand in close proximity to the surgeon andthe patient. The tray can also be positioned between the surgeon and thehead of the patient.

The tray can surround the head, or other desired area of the patientwhere the procedure is to be performed. For example, the tray cansurround the head of the patient 2 to thereby position the tray aroundthe head of the patient and between the surgeon and the head of thepatient. In such a configuration, the tray can also define and/orconfine the sterile field by surrounding the head or other desired areaand limiting access thereto.

The tray can be placed on or attached to a structure surrounding or nearthe surgical bed, chair, table, etc. The tray can be connected to orplaced on a structure such as a rail system, a stand, a tower, a bedside, a cart, a table, etc. For example, in some embodiments, the trayis configured to attach to an arm or wrist support attached to asurgical chair. The tray itself can then be used as both a tray and awrist or arm support.

Wrist supports are commonly used in many procedures, especiallyprocedures on the eye where precision and a steady hand is needed. Awrist support and/or the tray can be adapted to allow the wrist supportto be used to support the tray. Thus, the wrist support 12 is repurposedhere as a tray support. The tray can then provide support for userswrists and/or arms.

FIGS. 2 and 3 show respectively, a tray support 12 and the tray support12 mounted to a headrest of a surgical table or chair 13. A patientlying on the table 13 can have his or her head positioned on theheadrest such that the tray support 12 surrounds the patient's head.This can provide a support for the doctor, surgeon, nurse, etc. to restor steady the hands or arms during a procedure.

A tray 10 placed on the tray support 12 can surround a patient's head asshown in FIG. 1. The tray 10 can surround the patient's head while stillproviding support to one or more of a user's wrists and/or arms. Forexample, a surgeon could rest his or her forearms on the supportportions 11 of the tray 10. The support portions 11 can be free ofinstruments, tools or other features so that the surgeon is free to restand reposition his or her arms on the support portion 11 withoutinterference from other features.

In some embodiments, the support portion 11 is raised up higher thansome other parts of the tray. The support portion 11 may besubstantially flat. In some embodiments, the support portion 11 can bean elongated protrusion with a rounded or flat top surface above theother surfaces of the tray 10. In some embodiments, the support portion11 can be configured to be positioned at the sides of the doctor, sothat the doctor can be positioned closer to the patient with his or herelbows or forearms supported at his or her sides and at the sides of thetray. The tray 10 is shown with an inward contour 9 that allows the bodyof the doctor to be closer to the patient while his or her arms aresupported at the sides of the body and possibly near the back of thedoctor's body.

Returning to FIG. 2, an example tray support 12 is illustrated. The traysupport 12 can also be used for positioning a tray 10 within thesurgical field. The illustrated tray support 12 can connect to asurgical stand, table, chair 13, etc. at end 14, as shown in FIG. 2A.The tray support 12 can have a top support bar 16, such as theillustrated U-shaped ring. The support bar 16 can have a fixed oradjustable relationship to the surgical stand, table, chair 13, etc. towhich it is attached. The support bar 16 can have one of many differentshapes. For example, the support bar 16 can be circular, semi-circular,U-, V-, or L-shaped, or a box with three sides. The support bar 16 canbe made of a round or square bar, tube, or pipe. As illustrated, thesupport bar 16 is made of a square tube formed in a U-shape.

As has been mentioned, the tray 10 can be placed on or attached tostructure surrounding or near the medical bed, chair 13, or table suchas on the support bar 16 of the tray support 12. The tray 10 can beplaced on, slid onto, or otherwise secured to the support bar 16 (FIG.2B). The tray 10 can attach to the support bar 16 or other structure inone of many different ways.

Looking at FIGS. 3-6, the contour and shape of the tray 10 can be seen.The tray 10 can be shaped to not only surround a head or other desiredarea of a patient, but also to allow a particular positioning of thesurgeon with relationship to the patient. For example, the tray can bepositioned between the surgeon and the patient while also placing someor all of the instruments off to the sides of the patient. Theinstruments can also be within the doctor's peripheral vision. The shapeof the tray 10 can also facilitate attaching the tray to a particularstructure such as a tray support 12.

The shape of the tray 10 can optimize the utilization of available spacenext to or around the area of the patient 2 to be operated on. Forexample, around the patient's head, the combined tray 10 and the traysupport 12 can allow the surgeon to be sufficiently close to the patientwhile providing all of the necessary instruments within short reach ofthe surgeon. In addition, while utilizing the tray 10, the surgeongenerally does not need to even turn to the side or extend his or herreach as the instruments are at hand right where they are needed.

For example, as shown in FIGS. 3 and 6, the back of the tray 10 caninclude a cutout 50 that can, for example, allow for more room for thesurgeon's legs or body beneath the tray 10. The back (FIG. 6) of thetray is closest to the body of the surgeon and the front (FIG. 5) is theside closest to the patient (see FIG. 1), where the surgeon is sittingor standing directly behind the top of the patient's head. The cutout 50can also provide additional visual access below the tray 10 to assist inmounting the tray 10 to an appropriate structure, such as the supportbar 16 on the tray support 12.

The bottom of the tray, as shown in FIGS. 7 and 7A, as well as otherportions, can be shaped and/or contoured to facilitate attachment toparticular structures such as the support bar 16. The tray 10 caninclude a slot or space 54 sized to allow the tray 10 to fit on top ofthe support bar 16 of the tray support 12 (FIG. 7A). The slot 54 isshown formed across the various support ribs on the underside of thetray 10. The slot can also be formed in other ways. The slot 54 or otherattachment structure can allow the tray to attach to and/or cover all oronly part of the support bar 16.

In the front view of FIG. 5, it can be seen that the tray 10 can alsoinclude one or more holes 52. The holes 52 can cooperate with the slot54 cut into the supporting ribs on the underside of the tray 10 (FIGS. 7and 7A) to fit over and onto the support bar 16. The holes 52 can be oneof many different shapes. For example, the holes 52 can be round (asshown), or square. In addition, the holes can be shaped to work withdifferent shaped and/or sized support bars. For example, in theillustrated embodiments, the holes a round and the support bar has asquare cross-section. In some embodiments, the holes and the support barhave corresponding shapes.

The tray 10 may include one or more mechanisms for latching of the trayonto a surgeon's chair, a surgical platform, a separate stand, wristsupport 12, support bar 16, etc. The latching mechanism may include, forexample, a snap fit, a screw, a lock, a spring loaded locking handle,etc. Additionally, the slot 54 can be tight fitting over the support bar16 to minimize and possibly prevent undesired movement of the tray. Insome embodiments, the slot can be a deep slot that extends the entireheight of the support bar 16. The slot may also include one or more tabsthat extend around a portion of the underside of the support bar 16.

The tray 10 is preferably secured to or positioned on the support bar 16in a manner to not tip, tilt, or fall off the support bar 16 when thetray experiences downward or sideways pressure on any point of the tray.

The illustrated tray 10 can be mounted onto the support bar 16 asfollows: 1) the tray 10 is placed over the support bar 16 such that thefront of the tray is forward of the front ends or top of the “U” of thesupport bar 16, 2) when the holes 52 are near the front ends or top ofthe “U” of the support bar 16 the front of the tray is tilted downwardsand the tray is advanced backwards onto the support bar 16, with thefront ends or top of the “U” of the support bar 16 advancing through theholes 52, 3) the tray is then slid backwards onto the support bar 16until the entire length of the slot 54 is substantially positioned overthe support bar 16, 4) the tray 10 is un-tilted or straightened bylowering the back of the tray, thereby placing the tray completely onthe support bar 16. The curved shape of the support bar 16, the holes 52and the slot 54 all cooperate to maintain the tray on the support bar 16such that the tray will not be easily displaced from, tipped over, ortitled on the support bar 16.

Returning now to FIGS. 3 and 4, features relating to the use of thesterile surgical tray 10 will now be discussed. The tray 10 includesreceiving or mating structures 18 for receiving a plurality of surgicalinstruments. The receiving or mating structures 18 for receiving theinstruments may generally conform to the shape of a particularinstrument or may be general areas where instruments can be placed orheld that does not have a specific structure for a specific instrument.As used herein the term “mating” means without limitation a receptaclehaving a complementary shape for receiving part or all of an article.The mating structure 18 can include a recess or cavity in the tray 10having a shape that may hold a variety of instruments. The matingstructure 18 can have a protrusion, a cradle, a guide member, or otherstructures which receive and/or position an instrument on the tray 10.

The tray 10 can have sufficient area on the top surface to receive thesurgical instruments necessary for the surgery to be performed withsufficient space between the instruments to allow the surgeon to easilyand conveniently pick-up an instrument and return it to the tray 10.

The tray and/or pack can include a number of different surgicalcomponents which may be prepackaged and sterilized with the tray 10. Forexample, surgical components of the surgical pack can include: abiological tissue cutter, a tissue illuminator, an aspiration/infusiondevice, a disposable speculum/drape combination, cotton swabs, acontainer containing BSS, an infusion line, trocars, cannulas, forceps,etc.

If the sterile surgical tray 10 is for ophthalmic surgery the surgicalinstruments preferably include at least a biological tissue cutter, anaspiration instrument, and an infusion instrument. The biological tissuecutter may be at least one of a vitreous cutter, a lens emulsification,fragmentation, or cutting device, scissors, and a cautery knife.Aspiration may be incorporated into the biological tissue cutter, suchas is known in vitreous cutters and phacoemulsification (phaco) devices.The aspiration and infusion instruments may be a combined infusion andaspiration instrument, commonly referred to as an irrigation/aspiration(I/A) handpiece. If the surgical tray 10 is for vitreoretinal surgerythe infusion instrument may be an infusion cannula with connectedtubing.

Preferably tray 10 includes all or nearly all the instruments necessaryto perform the desired surgery. For instance, if the desired surgery isa vitrectomy of the eye, it can include a vitreous cutter, an irrigationinstrument, an illumination instrument, an aspiration source, aninfusion source, and passive surgical instruments (for example, notpowered), and possibly an air/fluid exchange source. If the desiredsurgery is a cataract removal from the eye, the instruments included inthe tray can be cataract extraction instruments such as a phaco device,a phaco needle, a capsule polish tool, an aspiration source, an infusionsource, and passive surgical instruments, and possibly an oil filledsyringe.

In the illustrated embodiment of FIGS. 3 and 4, the tray 10 can be usedfor ophthalmic surgery and includes a vitreous cutter 26, a diathermy orelectrocautery device 28, and an illumination device 30. The diathermyor electrocautery device 28 can be used to stop bleeding from smallvessels by destroying tissue using heat conduction, as is known.

Tray 10 also preferably includes structure for receiving additionalinstruments beyond the plurality of instruments that are prepackaged andsterilized with the tray 10; an example of which is the structure 18shown without any instrument thereon.

Also, at least one surgical instrument may be connected at manufactureto the tray 10 at various electrical, and/or fluid connections. As bestseen in FIG. 4, the tray 10 includes various electrical connectors 32,as well as various fluid connectors 34. The electrical connectors 32 canbe used to connect the surgical instruments to various features such asa power source and a controller. The fluid connectors 34 can be used toconnect the surgical instruments to various sources including fluid andvacuum sources.

Tray 10 may include structure forming a priming fluid reservoir 20 forreceiving one or more instruments during priming of the instruments witha surgical fluid such as balanced-salt solution (BSS). If a reservoir isnot provided the user may need to use a beaker or other container forpriming the surgical instruments and tubes with BSS. Fluid reservoir 20can be a self filling fluid reservoir 20. The fluid reservoir 20 canfill such as during a self check procedure after the control system hasbeen turned on. Self filling can be a step in the start up routine ofthe controller. The fluid reservoir 20 can fill with BSS.

The tray 10 can have a recessed top surface forming one or more troughs22, as best seen in FIG. 3. The tray 10 can also include one or morefluid wells 24 as best seen in FIG. 4. The trough 22 and fluid well 24can be used to retain fluid such as fluid ejected or leaked from theinstruments and fluid runoff from the surgical procedure.

A drape can be placed over a patient, such as over a portion of apatient's head (not shown) during ophthalmic surgery. If desired, thedrape can be attached to the tray 10 by any suitable structure such asadhesive tape, hook and loop material, or other structure. Fluid runofffrom the drape that occurs during surgery can be controlled using atleast one fluid retention trough 22 and/or fluid well 24 to collect thefluid.

Additional features, shown in FIGS. 3 and 4, some of which are describedin more detail below, include: power button 36, indicator panel 38, airinfusion control 40, oil infusion control 42, fluid reservoir receiver44, recessed storage bins 46 for trocars and other tools, and anaspirant fluid container 48. The aspirant fluid container 48 can receivefluid aspirated from the surgical site. In some embodiments, theaspirant fluid container 48 can include a colored float, ball, or bobberthat floats at the fluid surface to indicate the fluid level. Theaspirant fluid container 48 may also include a light. The light canfunction similar to the light in the fluid reservoir receiver 44 asdescribed below.

The indicator panel 38 may include at least one status indicator. Thestatus indicator can take many forms including a light emitting diode(LED), a display, numbers, icons, bar graphs, and/or an audible signalgenerator. In FIGS. 3 and 4, five groups of status indicators are shown.Each group of status indicators can be associated with a particularinstrument or function of the tray 10. The status indicators can providedifferent types of feedback to a user. The status indicators can bedifferent colors or have different numbers of lights. For example, if afluid reservoir includes a sensor the indicators could be red, yellow,and green in color to indicate to the user that a vacuum level isunacceptable (red), a vacuum level is approaching an unacceptable level(yellow), or the vacuum level is acceptable (green). Another example isthat the number of indicators illuminated can indicate the speed orenergy level. The indicator panel 38 may also indicate a power level ofa battery or fuel cell, a fluid level of a pump fluid reservoir attachedto the input and output connectors or an illumination level of anilluminator attached to the input and output connectors.

The tray 10 may also have a control unit 60 including a processor forreceiving inputs from a user, from a plurality of surgical instruments,and from other devices and for transmitting signals to the same. Thecontrol unit 60 is preferably connected to tray 10 after tray 10 isopened and is being prepared for surgery. The control unit 60 mayalternatively be prepackaged and sterilized with tray 10.

As can be seen in FIGS. 3 and 4, the surgical tray 10 can provide theneeded tools in a configuration that is ready to use after opening ofthe tray. The tray can provide these tools organized in a manner thathas been optimized for the particular surgical procedure. For example,the support portions 11 can be free of instruments, tools or otherfeatures, while the some or all of the instruments are off to the sidesof the patient providing easy access to the doctor or surgeon. Thesurgeon generally does not need to even turn to the side or extend hisor her reach as the instruments are at hand right where they are needed.In addition, various features of the tray 10 have been optimallypositioned. For example, the power button 36 is spaced away from thedoctor and away from the support portions 11 to prevent accidentaldepressing of the power button 36. Also, the fluid container in thefluid reservoir receiver 44 is also spaced away from the doctor. Thisensures that the bottle in the fluid reservoir receiver 44 is not in theway, but also provides line of sight access for the surgeon to be ableto view the fluid level.

The panel 38 and the fluid reservoir receiver 44 can also be positionedto the outside of the tray. This can allow the surgeon to use peripheralvision or only eye movement without diverting her head, for example,from a surgical microscope. This can increase the ergonomics of the trayand decrease distractions from head movements. Additionally, the mainfluid and electrical components are separated to the opposite sides ofthe tray 10. The power button 36, control unit 60, and indicator panel38 are on one side and the fluid reservoir receiver 44 and the aspirantfluid container 48 are on the other side.

In certain embodiments, the sterile surgical tray 10, as best seen inFIG. 7, also includes one or more pumps 56. As shown, each pump 56 isdriven by an electric motor 58. The one or more pumps 56 can be used forvarious purposes, such as to provide aspiration, to provide apressurized source of fluid, to remove material from the eye, etc.

A pump 56 can be an infusion pump operatively connected to the fluidreservoir or receptacle receiver 44. The fluid reservoir receiver 44 maybe for receiving a fluid reservoir (described and shown below) forinfusing fluid such as a surgical irrigation solution into a surgicalsite. A pump 56 can be an aspiration pump for collecting aspiratedtissue and fluid during surgery. In some embodiments, the aspirationpump can pump aspirated tissue and fluid into the aspirant fluidcontainer 48. The pump 56 may be one of a vacuum pump (for example, arotary vein or diaphragm) or a positive displacement pump (for example,peristaltic or scroll).

Tray 10 may also include a syringe pump (not shown) for injecting oil orother fluids into the eye. With reference to FIGS. 4 and 7, the syringepump can connect to one of the fluid connectors 34 and possibly to oneof the electrical connectors 32. In particular, one of the fluidconnectors 34 can be connected to the oil infusion control 42. The oilinfusion control 42 can be used to control the flow of oil. The oilinfusion control 42 as shown is the handle of a stopcock 62, but thecontrol 42 can include a pump and/or solenoid valve. The stopcock 62 canbe fluidly connected to one or more of the fluid connectors 34, and/or asurgical instrument.

The infusion pump 56 can also be connected to a stopcock 64. Thestopcock 64 can be connected to the fluid reservoir through a fluidreservoir receiver 44. The stopcock 64 can be used to inject air intothe eye during a procedure. For example, after fluid has been removedfrom the eye, air can then be injected into the retina during all orpart of a procedure on the retina. The stopcock can control whetherfluid or air is injected by an instrument such as the vitreous cutter26. The air infusion control 40 as shown is the handle of a stopcock 64,but the control 40 can include a pump and/or solenoid valve.

The infusion pump 56 may also be connected to the syringe pump or an oilreservoir. Thus, the infusion pump 56 in this configuration can beconnected to an infusion device that can infuse one or more of a fluid,such as balanced-salt solution (BSS); air; or oil into the eye.

FIG. 8 shows a block diagram of a fluid-air exchange system 300 that maybe incorporated into a sterile surgical tray, such as tray 10. System300 preferably includes a BSS reservoir 302, a reservoir 304 of air,connected to a selector valve 306 for selecting which fluid, BSS or air,will be allowed to flow into infusion pump 308. Infusion pump 308 may beany suitable pump for infusing fluid into an eye or other body part. Abypass valve 310 connects a flow path from infusion pump 308 and an oilreservoir 312. Oil reservoir 312 is connected to a source of oil 314 viaa check valve 316. Oil source 314 may be a syringe, as shown or may beanother source that is connected to a pump (not shown) for automaticallypumping oil into reservoir 312. Oil reservoir is then connected to athree-way stopcock valve 318 via another check valve 320. Depending onthe positions of the valves 306, 310, and 318 air, BSS, or oil(typically silicone oil) will be infused into an eye. Bypass valve 310allows infusion pump and air or BSS to push oil from reservoir 312 intoan eye.

Turning now to FIGS. 9-10, the two sides of the tray 10 are shown. Thetray 10 in these views also includes a BSS container 70 that has beenconnected to the tray 10, as described in more detail below.

In FIG. 10, and also in FIG. 11, it can be seen that a control unit 60may be connected to the tray 10. The control unit 60 can include aprocessor for receiving inputs from a user, from a plurality of surgicalinstruments, and/or from other devices and can transmit signals to thesame.

The control unit 60 can be made as a cartridge that can be received intothe tray 10. Referring in particular to FIG. 11, it can be seen that thecartridge-like control unit 60 can be inserted into a slot 66 in thetray 10.

The tray 10 with control unit 60 can provide all necessary surgicaltools for an operation, as well, as power and the control systems forthose tools. Additionally, the tray can provide the tools in a ready touse configuration, such as already plugged in to power connectors, fluidconnectors, aspiration connectors, etc. so that once the cartridge-likecontrol unit 60 is plugged into the tray 10 the surgeon can start theprocedure with minimal to no additional preparation. The tray can be adisposable tray with all of the necessary surgical tools for anoperation, and the control unit 60 can be a reusable control unit 60that can be plugged into or otherwise connected to the disposable tray.

The cartridge-like control unit 60 can have a pair of rails 68 on thesides of the control unit 60. The rails 68 can be received by grooves 72in the slot 66 on the tray. The cartridge can be slid into the slot 66with the rails 68 engaging the grooves 72 until the button lever 74engages the tray 10. The grooves and rails and/or housing shape can bearranged such that the cartridge control can only be inserted in oneorientation to prevent the user from inserting the cartridgeincorrectly. The button lever 74 can include a handle 76 that can allowthe button lever to be moved. The button lever 74 can be hingedlyattached to the control unit 60 and biased towards an upright position.The button lever 74 can include internal spring. Pressing down on thehandle 76 can move the button lever 74 downwards. An outer edge of thebutton lever 74 can engage an edge of the slot 66 in the tray. Thisengagement can keep the control unit 60 locked in place in the tray. Itcan also be seen that the control unit 60 has a handle 78 on undersideof the control unit. The handles 78 and 76 can be used in conjunction tosecure the control unit 60 while installing or removing the control unit60 from the tray 10.

The control unit 60 can be provided with electrical connections (FIG.14). The tray can also have corresponding electrical connections. Thiscan allow the control unit to automatically engage the electricalconnections of the tray when the control unit is inserted into the slotand engaged with the tray. The control unit 60 may be entirelyself-contained or may require additional plug-ins such as outside powersources and other electrical or network-type connections.

In the case where the control unit 60 is connected to the tray 10 afterthe tray/pack is opened, it may not be necessary for the control unit 60to be sterile. This is because the slot 66 in the tray is on a lowerportion of the tray 10 which generally would not be in the sterile fieldor may be covered by a sterile drape.

The control unit 60 can have a processor (e.g., a microprocessor, ASIC,and/or circuitry and drive mechanism) and power configured to controland provide power to various instrumentations that require power andcontrol on or attached to the tray 10. For example, the control unit 60may be configured to power and control the vitreous cutter 26, thediathermy device 28, the illumination device 30, the motors 58 and/orthe pumps 56. The control unit 60 may be equipped for wired or wirelesscommunication. For example, the control unit 60 may communicate with theillumination device 30 for receiving current operating parameters, suchas, for example, a current illumination level. In this manner, all thenecessary logic, circuitry, and power can reside within the tray 10itself and/or instruments in communication with the tray without havingto resort to a separate control console. The control unit 60 preferablyincludes batteries and is rechargeable.

Looking to FIG. 17, there is illustrated one embodiment of a controlunit 60 that can be used with the tray 10. FIG. 17 illustrates a blockdiagram of a control unit 60 that is in communication with one or morehandheld instruments 516 and/or computing systems 517 and/or datasources 519 via one or more networks 510. The control unit 60 may beused to implement one or more of the systems and methods describedherein. In addition, in one embodiment, the control unit 60 may beconfigured to process status data and/or information from surgicaldevices. While FIG. 17 illustrates one embodiment of a control unit 60,it is recognized that the functionality provided for in the componentsand modules of control unit 60 may be combined into fewer components andmodules or further separated into additional components and modules.

In one embodiment, the control unit 60 comprises a central processingunit (“CPU”) 502, which may comprise a microprocessor. The control unit60 further comprises a memory 504, such as random access memory (“RAM”)for temporary storage of information and/or a read only memory (“ROM”)for permanent storage of information, and a mass storage device 508,such as a hard drive, diskette, or optical media storage device.

The control unit 60 can comprise one or more commonly availableinput/output (I/O) devices and interfaces 512, such as a keyboard,mouse, touchpad, and printer. In one embodiment, the I/O devices andinterfaces 512 comprise one or more display devices or touch screendisplay devices, such as a monitor, that allows the visual presentationof data to a user. The I/O devices and interfaces 512 can also provide acommunications interface to various external devices. The control unit60 may also comprise one or more multimedia devices 510, such asspeakers, video cards, graphics accelerators, and microphones, forexample. It will be understood that in some embodiments, the componentsdiscussed with regard to the control unit 60 can be physically locatedin the control unit 60, in the tray 10, or in another location.

In the embodiment of FIG. 17, the control unit 60 is coupled to anetwork 510, such as a LAN, WAN, or the Internet, for example, via awired, wireless, or combination of wired and wireless, communicationlink 514. The network 510 communicates with various computing devicesand/or other electronic devices via wired or wireless communicationlinks. In the exemplary embodiment of FIG. 17, the network 510 iscommunicating with one or more handheld instruments 516, computingsystems 517, and/or data sources 519. The control unit 60 may alsoinclude one or more pumps 56. Alternatively, the one or more pumps 56can be part of a separate module or unit that can be connected to thetray. In this way, the one or more pumps can also be reusable which canreduce the cost of the tray 10.

Moving now to FIGS. 18 and 19, a detail of the tray 10 is shown. Inparticular, a fluid reservoir receiver or receptacle 44 is shown. Thefluid reservoir receiver 44 can receive a reservoir or container offluid, such as a bottle of balanced-salt solution (BSS). The fluidreservoir receiver 44 can be used to receive the fluid and then thefluid can be used by other components of the tray 10. For example, thefluid can be used by an infusion device and can be connected to theinfusion pump 56 to pump the fluid to the infusion device and into theeye.

The fluid reservoir receiver 44 can be shaped like a bowl or acontainer. The fluid reservoir receiver 44 can be contoured toaccommodate the shape of the desired fluid container. Preferably, thefluid reservoir receiver 44 can hold at least some fluid, if the fluidwere to leak or be spilled from the container. As shown, the fluidreservoir receiver 44 has a substantially cylindrical wall and a planerbottom surface, though other cross-sectional shapes could be used, suchas square, rectangular, polygon, etc.

The fluid reservoir receiver 44 can include a spike 80 or other deviceto gain access to the fluid within the bottle or container. As shown,the spike 80 is a vented spike having a fluid channel 82 and an airchannel 84. Fluid can flow from the bottle or container through fluidchannel 82 which passes into the tubing 90 connected with the spike 80.The tubing 90 can be connected to an infusion pump and/or an infusioninstrument. The spike 80 can also include an air vent such as airchannel 84. A filter 86, such as a hydrophobic air filter, can be usedto allow air to flow into the spike while preventing fluid from exitingthe spike through the air channel 84 and through the filter 86. In thisway, the vented spike 80 allows for fluid to be removed from thecontainer or bottle while at the same time allowing air to be introducedinto the bottle. This reduces any pressure differential between theinterior of the bottle and the atmosphere. This also allows the fluid tocontinuously exit the bottle as desired without becoming plugged orforced out because of the pressure differentials. Or alternatively, theair channel 84 may be connected to an infusion pump to pressurize thebottle or container so as to force fluid through tubing 90 as desired.

The fluid reservoir receiver 44 can also include a light 88. As manyprocedures in the eye are performed in the dark, a light 88 in the fluidreservoir receiver 44 can beneficially inform the surgeon as to thefluid level of the container or bottle of BSS fluid. The light 88 can bewithin, around, or outside of the fluid reservoir receiver 44. The light88 is preferably located in the bottom surface of the fluid reservoirreceiver 44, but can be positioned in other locations as well.

As illustrated in FIGS. 18 and 19, the light 88 is positioned next tothe spike 80. The light 88 can be positioned in a radially middlelocation between the center of the fluid reservoir receiver 44 where thespike is located and the side wall. This allows the light 88 to bepositioned next to a thin wall portion of the fluid bottle that isconnected to the spike 80 within the fluid reservoir receiver 44. Itwill be understood that generally a conventional BSS bottle will have athin wall portion between the neck and shoulder of the bottle. This willallow for increased light transmission through the bottle.

The light 88 can be received to form a fluid tight seal in the bottom ofthe fluid reservoir receiver 44. This way, if fluid leaks from thebottle it will be less likely to leak out of the tray 10 or the fluidreservoir receiver 44.

With the light 88 positioned in the bottom surface of the fluidreservoir receiver 44, the rays of light from the light 88 pass throughbottle or container and through the fluid. The light 88 can highlightthe fluid meniscus showing the level of fluid within the bottle. Themeniscus is the curved upper surface of a column of liquid, thecurvature of which is caused by surface tension between the fluid andthe wall of the bottle or container. The light 88 is preferably an LEDand is preferably a darker color so as to not distract from the surgicalprocedure. Example colors include blue, amber, purple, green, etc. Othertypes of lights, such as incandescent, florescent, and halogen, can alsobe used.

The illustrated configuration also beneficially prevents the light fromshining directly into the surgeon's eyes or from otherwise becoming adistraction during the surgical procedure. Other systems can also beused to highlight the fluid level in the dark while not shining thelight directly into the surgeon's eyes or otherwise being a distractionduring the surgical procedure.

In many instances, a sterile user, such as a surgeon, may require theassistance of a non-sterile user without compromising the sterile field.For example, the surgeon may need the assistance of a non-sterile userto place or replace a sterile BSS bottle or other fluid, medication,injectable medication, intravenous solution or other container withinthe sterile field, such as on the tray 10, without compromising thesterile field.

FIG. 20 illustrates a device 110 that can be used to place a sterileitem, such as a bottle within a sterile field without comprising thesterile field. The device 110 can also be used for other purposes.

The device 110 can be a container configured to hold a bottle,instruments, medication, tools, etc. The container 110 can have aninternal chamber 120 with at least one opening 122. The internal chamber120 and opening 122 can be used to hold or store other items. In someembodiments, the container 110 can further include a lip 124.

Turning now to FIG. 21, it can be seen that some embodiments a lid 126can cover the top of the container 110. The lid 126 can seal the opening122 and internal chamber 120. For example, the container and/or theinternal chamber 120 can be sterilized and a sterile lid 126 can then beattached to the container 110. Alternatively, the lid 26 can be a TYVEK®lid that can allow the container 110, the internal chamber 120, andanything within the internal chamber 120 to be sterilized together. Thiscan maintain the internal chamber 120 in a sterilized configuration, atleast until the lid 126 is removed or the sealed internal chamber 120 isotherwise breached.

The lid 126 can attach to the lip 124. As shown, the lid 126 is a TYVEK®lid or other similar material. The lid 126 can be any type of lid thatcan maintain the internal chamber 120 in a sterile condition.

In some embodiments, an item that has been previously sterilized can beplaced within the internal chamber 120. The lid can then be placed onthe container 110. Alternatively, or in addition, an item and theinternal chamber 120 can be jointly sterilized prior to attaching thelid 126, or after the lid 126 has been attached.

In some embodiments, the container 110 and an item can be sterilized(jointly or separately), the item can be placed within the container,and the container is then placed within a further container such that alid 126 is unnecessary. The further container could be packaging or amedical kit, for example. The container 110 and the item could also besterilized while within the further container.

FIG. 22 illustrates an embodiment of the container 110 with a bottle 70within the internal chamber 120 of the container 110. The bottle 70 cancontain any of a number of different substances including IV fluid,saline, and medication. In a preferred embodiment, the bottle 70 is asterile bottle containing balanced-salt solution (BSS).

In some embodiments, all or part of the container 110 can be flexibleand/or malleable. This flexibility and malleability can allow a user toexert forces on the container that can be imparted to item(s) within thecontainer 110. For example, the container 110 can have a compressiblesection 130. In some embodiments, the compressible section 130 comprisesan accordion shaped feature that can allow the container to becompressed and/or decrease in size.

FIGS. 23A-B illustrate one embodiment of a container 110 where thecompressible section 130 is moved to the compressed state, decreasingthe size of the container 110. In comparison to FIG. 23A, where thebottle 70 was completely within the container 110, in FIG. 23B thebottle 70 now extends past the opening 122 and lip 124 of the container.The compressible section 130 can allow a user to have increased controlover the movement of an item within the container. The compressiblesection 130 can be used to, for example, force an item out of thecontainer 110. The compressible section 130 can also allow the force tobe applied to the item as it leaves the container 110, as will befurther explained below.

As one example, the container 110 can be used to advance the bottle 70onto a spike in the fluid reservoir receiver 44 of the tray 10. Thecompressible section 130 can allow the doctor or nurse to apply thenecessary pressure on the bottle, so that the spike can pierce theseptum or lid of the bottle. This can provide access to the BSS fluidwithin the bottle 70 to the various instruments on the tray. Forexample, the infusion pump 56 can be used to pump BSS fluid from thebottle 70 to the vitreous cutter 26. The container 110 canadvantageously allow a non-sterile user, such as a nurse to load the BSSfluid onto the sterile tray 10 without compromising the sterile field.

Some example uses of the container 110 will now be described.

As has been previously mentioned, a sterile field can be established fora medical or surgical procedure that may involve a tray or pack 10. Insurgery, a sterile pack can be shipped from a manufacturer to a surgerycenter. An example of which is ophthalmic surgery (vitreoretinal orcataract surgery, in particular). These packs can contain several itemsthat are typically used in surgery and include one-time use surgicalinstruments, fluid cassettes, tubing sets, drapes, needles, and otherdevices. The particular content of a pack depends on the type of surgeryand perhaps the individual preference of the surgeon or surgical center.

When preparing for surgery, a sterile drape can be placed over a tray.The contents of the sterile pack and perhaps additional sterileinstruments and materials are spread-out over the tray so that thematerials and instruments necessary for the surgery are readilyavailable to a nurse or surgeon. A sterile pack can also be providedwhere many of the instruments and tubing sets are organized and placedin mating recesses of the pack so that the pack can act as a tray for atleast some of the instruments in surgery. In such an example, a steriledrape may not be needed.

Often times, after the pack is opened, the components within the packare retrieved and transferred to a conventional tray, as is known in theart, or back table in an operating room such that a surgeon can retrieveand, if he/she desires, place back any of the components during anoperation. Often times, a scrub nurse or surgical assistant performsthis transfer.

The components within a pack or for a surgical procedure can varysubstantially. For example, surgical components of a surgical pack foran ophthalmic procedure can include: a biological tissue cutter; atissue illuminator; an aspiration/infusion cassette; a disposablespeculum/drape combination; a self stabilizing lens ring with the lenspre-mounted; a gas exchange syringe; Q-tips; a sterile containercontaining balanced salt solution (BSS); an infusion line; trocars withcannulas pre-mounted; and goniosol.

In some procedures, the aspiration/infusion cassette is mounted directlyinto the tray. This eliminates the need for separate setup of theaspiration/infusion cassette. An aspiration line connects the biologicaltissue cutter to the aspiration chamber of the cassette for removingtissue cut or dislodged by the cutter during surgery. The infusion lineconnects the infusion chamber of the cassette and allows infusion offluids such as, for example, the balanced salt solution, to replace theaspirated materials.

Referring now to FIGS. 24-27, the tray 10 can accept a sterile container70 of balanced salt solution directly into the tray. This can allow thecontainer 70 to be connected to a pump that can allow the infusion offluids into the eye, for example. The container 110 can be used tofacilitate the installation, placement and/or replacement of thecontainer 70 into the fluid reservoir receiver 44 of the tray 10.

The following steps may be taken during a surgical procedure to mountthe container 70 onto the tray 10. The below steps can be performed by anon-sterile user without comprising the sterile field.

1) The lid 126 can be removed from the container 110, and/or thecontainer 110 can be removed from packaging. The container 110 cancontain a sterile bottle 70 of IV fluid, such as BSS.

2) The container 110 can be turned upside down to insert the bottle 70into the fluid reservoir receiver 44 of the tray 10 as shown in FIG. 24.The bottle 70 can be held in place within the container 110 by grip ofthe user, or by a slight friction fit between the bottle and thecontainer. The bottle 70 may be loose inside the container 110 so as tobe able to slide out without additional force, or with minimal force.

3) The container 110 can be placed over the fluid reservoir receiver 44of the tray 10 with the top down so that the opening 122 of thecontainer is adjacent the top opening of the fluid reservoir receiver 44(FIG. 25). The bottle 70 can be allowed out of the container into thefluid reservoir receiver 44.

4) With the bottle placed within or over the fluid reservoir receiver 44(FIG. 25), a downward force can be applied to the bottom of thecontainer 110 (FIG. 26). This force can be a way to ensure that thebottle is securely attached to the tray. This movement may also serve toprovide other functions such as puncturing an end of the bottle with thespike 80 (FIGS. 18-19) within the tray or locking the bottle in place.

This downward force can collapse the collapsible section 130. This isbecause the lip 124 of the container is positioned on the tray 10 so theforce can be sufficient to cause the collapsible section to decrease insize. The force can cause the compressible section 130 to compress, suchas in an accordion fashion.

The force can also push the bottle 70 downward. This can cause thebottle to leave the container. When the fluid reservoir receiver 44includes a spike 80, the force can also press the bottle onto the spike.The spike can advance through the bottle, such as through a septum orlid of the bottle. The bottle can then be fluidly connected to the trayso that the pump 56 can draw fluid from the container to be used at oneor more parts of the tray. For example the fluid can be provided to aninstrument, such as a vitreous cutter 26 and to a priming fluidreservoir 20.

5) Once the bottle 70 is securely in place, the container 110 can beremoved and discarded. The BSS container is then contained in the fluidreservoir receiver 44 of the tray 10 as shown in FIG. 27.

Preferably, the above method steps are performed by a non-sterile user.Because the container 110 is removed and discarded, and the user doesnot contact the bottle 70 and the sterile field is generally notcompromised. The outside surface of the bottle 70 is preferably sterileand the sterile container 110 which may have been touched by thenon-sterile user has been removed. The container 110 allows thenon-sterile user to attach the bottle 70 to the tray without having totouch any part of the tray or the bottle.

Should the surgeon or sterile user require an additional or new bottle70, such as of BSS solution, the sterile user can assist withoutcompromising the sterile field. The sterile user can remove and discardthe empty sterile bottle 70 from the tray 10 and the above steps canthen be repeated to install a new bottle 70.

A person of skill in the art should recognize that one or more of thesteps may vary depending on the type of surgery performed. For example,all of the above steps can be performed by a sterile user such as asurgeon.

As another example, the container 110 can also be used to cover a devicehaving a non-sterile exterior. For example, the container 110 can besterilized and a bottle having a non-sterilize exterior or other itemcan be placed within the container 110. The container. 110 can provide aprotected, sterile covering for the bottle so as to not compromise thesterile field.

As an example for a method of use, a bottle having a non-sterileexterior, such as a bottle containing BSS can be placed within thecontainer 110. The container 110 can then be used as described above, tosecure the bottle 70 to the tray 10. The container 110 can remaincovering the bottle 70, as in FIG. 26. This can provide for a sterilesurface within the sterile field, while still allowing for the use of abottle or item having a non-sterile exterior.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. In addition, while a number of variations of the invention havebeen shown and described in detail, other modifications, which arewithin the scope of this invention, will be readily apparent to those ofskill in the art based upon this disclosure. It is also contemplatedthat various combinations or sub-combinations of the specific featuresand aspects of the embodiments may be made and still fall within thescope of the invention. Accordingly, it should be understood thatvarious features and aspects of the disclosed embodiments can becombined with or substituted for one another in order to form varyingmodes of the disclosed invention. Thus, it is intended that the scope ofthe present invention herein disclosed should not be limited by theparticular disclosed embodiments described above, but should bedetermined only by a fair reading of the claims that follow.

Similarly, this method of disclosure, is not to be interpreted asreflecting an intention that any claim require more features than areexpressly recited in that claim. Rather, as the following claimsreflect, inventive aspects lie in a combination of fewer than allfeatures of any single foregoing disclosed embodiment. Thus, the claimsfollowing the Detailed Description are hereby expressly incorporatedinto this Detailed Description, with each claim standing on its own as aseparate embodiment.

1. A surgical apparatus for use by a surgeon during a surgical procedurecomprising: a sealed sterilized surgical pack comprising: a plurality ofsurgical instruments; and a surgical tray being substantially shaped tofit around a body part of a patient and comprising: a top surfaceconfigured to be part of a sterile field of a surgical procedure; aplurality of receiving structures located on the top surface, each ofthe plurality of surgical instruments removably positioned in acorresponding one of the receiving structures; at least one electricalconnector, at least one of the plurality of surgical instruments beingconnected to the at least one electrical connector; at least one fluidconnector, at least one of the plurality of surgical instruments beingconnected to the at least one fluid connector; and a side or bottomsurface configured to be outside of the sterile field, the side orbottom surface comprising a control unit receiver, the control unitreceiver being electrically coupled to the at least one electricalconnector; and a control unit configured to be received into the controlunit receiver after the surgical pack has been opened, the control unitconfigured to power and control operation of at least one of theplurality of surgical instruments.
 2. The surgical apparatus of claim 1,wherein the control unit receiver is positioned below the sterile field.3. The surgical apparatus of claim 1, wherein the control unit isnon-sterile.
 4. The surgical apparatus of claim 3, wherein the controlunit further comprises rechargeable batteries.
 5. The surgical apparatusof claim 1, further comprising at least one pump connected to the atleast one fluid connector, the control unit receiver being electricallycoupled to the pump.
 6. The surgical apparatus of claim 1, wherein theplurality of surgical instruments comprises a biological tissue cutter,and a tissue illuminator.
 7. The surgical apparatus of claim 1, whereinthe tray further comprises a receiver for receiving a container offluid.
 8. The surgical apparatus of claim 7, wherein the receivercomprises a spike and a light positioned within the recess for shininglight through the container of fluid to indicate a fluid level to thesurgeon.
 9. The surgical apparatus of claim 1, wherein the tray isconfigured to sit on a surgical stand to a side of or on top of thepatient.
 10. The surgical apparatus of claim 1, wherein the surgicaltray being substantially shaped to fit around the body part of thepatient comprises the surgical tray being substantially U-shaped. 11.The surgical apparatus of claim 10, wherein the surgical tray furthercomprises a mating recess on a bottom side of the tray, the matingrecess configured to receive a portion of a tray support on a surgicaltable or chair such that the tray can be attached to the tray support.12. A surgical apparatus for use by a surgeon during an ophthalmicsurgical procedure comprising: a plurality of surgical instruments; anda surgical tray being substantially shaped to fit around the head of apatient and comprising: a plurality of receiving structures located onan upper side of the tray, each of the plurality of surgical instrumentsremovably positioned in a corresponding one of the structures; a recessfor receiving a container of fluid, the recess comprising: a spike forinsertion into the container of fluid; a light positioned within therecess for shining light through the container of fluid to indicate afluid level to the surgeon; and wherein the plurality of surgicalinstruments and the surgical tray are prepackaged and sterilizedtogether.
 13. The surgical apparatus of claim 12, wherein the tray isconfigured to sit on a surgical stand to a side of or on top of thepatient.
 14. The surgical apparatus of claim 12, wherein the spikecomprises a vented spike having a first channel, a second channel, and ahydrophobic filter, the first channel connected to at least one pump viatubing and the second channel connected to the hydrophobic filter toallow air into the channel.
 15. The surgical apparatus of claim 12,wherein the tray is electrically coupled to a control unit configured tocontrol an operation of at least one of the plurality of surgicalinstruments.
 16. The surgical apparatus of claim 12, wherein theplurality of surgical instruments comprises a biological tissue cutter,and a tissue illuminator.
 17. The surgical apparatus of claim 12,wherein the light is a light emitting diode (LED).
 18. The surgicalapparatus of claim 17, wherein the LED is one of blue, amber, purple,and green.
 19. The surgical apparatus of claim 12, wherein the light isone of blue, amber, purple, and green.
 20. The surgical apparatus ofclaim 17, wherein the surgical tray being substantially shaped to fitaround the head of the patient comprises the surgical tray beingsubstantially U-shaped. 21-33. (canceled)